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Turning Dysfunction After Stroke: Assessment and Intervention

NCT ID: NCT04668573

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2020-10-31

Brief Summary

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The study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on turning performance, trunk control and motor function in stroke patients.

Detailed Description

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This study has two parts. The first part is a cross-sectional observatory study.Eligible stroke and healthy subjects are asked their demographic data and assessed for turning performance (stepping patterns and electromyography data of trunk muscles), trunk control (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor function (recovery of extremities and balance function). The second part is a randomized controlled trial. Stroke participants are randomly allocated into trunk exercise and control groups. Trunk exercise group receives trunk exercise including trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks while control group remains their regular activities. Turning performance, trunk control and motor function are evaluated before and after training session.

Conditions

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Stroke Walking, Difficulty Balancing Interference

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Trunk exercise group

Participants received trunk exercise for 30 minutes per session, twice a week for 12 weeks.

Group Type EXPERIMENTAL

Trunk exercise

Intervention Type OTHER

Trunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks.

Control group

Participants remained their regular activities.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trunk exercise

Trunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age between 20 and 80 years old
* survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study
* able to walk independently over a distance of 10 m without walking aids or orthoses
* able to provide informed consent and follow instructions.

Exclusion Criteria

* having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment
* having cognitive problems with a Mini-Mental State Examination score less than 24 or aphasia that could prevent subjects from following instructions.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University

OTHER

Sponsor Role collaborator

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Pei Jung Liang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pei-Jung Liang

Role: PRINCIPAL_INVESTIGATOR

Taichung Tzu Chi Hospital

Locations

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Taipei Tzu Chi Hospital

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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08-XD-051

Identifier Type: -

Identifier Source: org_study_id